A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Galderma R&D
Study ID
NCT04501679
Phase
PHASE3
Status
Completed

Conditions

  • Prurigo Nodularis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — DRUG
    Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
  • Placebo — DRUG
    Participants received matching placebo as SC injection.

Study Details

The primary objective was to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (\>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

Key Dates

Start date
Aug 11, 2020
Status verified
Jul 2024
Primary completion
Mar 30, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
274 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab
    Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.
  • Placebo Comparator: Placebo
    Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.

Primary Outcome Measure

Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16 [ Time Frame: Baseline, Week 16 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Galderma Investigational SiteFountain ValleyCalifornia92708-
Galderma Investigational SiteSan DiegoCalifornia92123-
Galderma Investigational SiteWashington D.C.District of Columbia20037-
Galderma Investigational SiteAventuraFlorida33180-
Galderma Investigational SiteMiamiFlorida33136-
Galderma Investigational SiteNorth Miami BeachFlorida33162-4708-
Galderma Investigational SiteOrmond BeachFlorida32174-
Galderma Investigational SiteChicagoIllinois60602-
Galderma Investigational SiteIndianapolisIndiana46250-
Galderma Investigational SiteLouisvilleKentucky40241-
Galderma Investigational SiteBostonMassachusetts02111-
Galderma Investigational SiteSaint JosephMichigan49085-
Galderma Investigational SiteNew YorkNew York10021-
Galderma Investigational SiteCincinnatiOhio45627-
Galderma Investigational SiteDublinOhio43016-
Galderma Investigational SiteAndersonSouth Carolina29621-
Galderma Investigational SiteMurfreesboroTennessee37130-
Galderma Investigational SiteDallasTexas75230-
Galderma Investigational SiteDripping SpringsTexas78620-
Galderma Investigational SitePflugervilleTexas78660-
Galderma Investigational SiteWebsterTexas77004-
Galderma Investigational SiteMorgantownWest Virginia26505-

Find similar trials in Fountain Valley, CA

By research site
Galderma Investigational Site· Fountain Valley, CAGalderma Investigational Site· San Diego, CAGalderma Investigational Site· Washington D.C., DCGalderma Investigational Site· Aventura, FLGalderma Investigational Site· Miami, FLGalderma Investigational Site· North Miami Beach, FL

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